MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFLOW CONSOLE; ARTHROSCOPE

Model Number 0450000000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)

Patient Problems Extravasation (1842); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that there was extravasation.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: pump does not stop.Probable root cause: pressure sensor malfunction/out of calibration; inflow cassette/ tubing pressure sensor membrane failure; mis-inserted cassette/ tubing; motor encoder malfunction/failure (inflow and/or outflow); roller wheel assembly (inflow and/or outflow) malfunction/failure; roller wheel failure due to peristaltic tubing debris build-up; main board (all) /imx failure (cf); software malfunction; use error; system design; unwanted movement of internal components/wiring; pressure sensor is operated above linear pressure reading range (>450 mmhg for cf) (design); pump operated at least-favorable environmental conditions for extended period of time; run screen does not adequately indicate overpressure situation; miniwashmalfunction (cf); command not registered from hand control (all), footswitch (cf), sidne (fc, ap) or hermes (ap-hermes ready); excessive use of wash or turbo; slow reaction time to a quickly closed off shaver outflow at high flow rates; power failure of pump; pressure sensor stuck behind the sensor bracket; electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge; insufficient cybersecurity (cf).Serial number is unknown; therefore, manufacture date can not be confirmed.The failure mode will be monitored for future reoccurrence.H3 other text : 81.

Event Description

It was reported that there was extravasation.

• Brand Name: PKG, CROSSFLOW CONSOLE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12701354
• MDR Text Key: 278524789
• Report Number: 0002936485-2021-00568
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327058048
• UDI-Public: 07613327058048
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0450000000
• Device Catalogue Number: 0450000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other